Clinical Trial Details
Braintumor Website

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NCT02278510 : Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma
PhasePhase 0
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically confirmed diagnosis of supratentorial WHO Grade III or IV (High Grade
Glioma) that has undergone surgical biopsy or resection followed by adjuvant
chemoradiotherapy, that has evidence of recurrence or progression based on imaging
studies and a sterotactic biopsy is indicated for confirmation of

- Karnofsky Performance Status 70-100

- MRI demonstration of a stereotactically accessible enhancing mass of less than 40cm3
that does not require resection to relieve clinically significant mass effect

- Patient understands the procedures and agrees to comply with the study requirements
by providing written informed consent

Laboratory values within the following ranges:

- Absolute neutrophil count (ANC)>=1,500/microliter

- Platelet count>=100,000/microliter

- Hemoglobin>=10g/dL

- Normal PT/PTT

- Estimated glomerular filtration rate (eGFR) of at least 50mL/min

Exclusion Criteria:

- Patient is mentally or legally incapacitated at the time of the study

- Known HIV(+) or has been diagnosed with AIDS

- Participation in another investigational drug study in the prior 8 weeks

- Positive pregnancy test in a female

- Patient, in the opinion of the investigator, is likely to be poorly compliant

- Diffuse subependymal or CSF disease

- Tumors involving the cerebellum

- Tumor enhancement involving both hemispheres

- Active infection requiring treatment

- Unexplained febrile illness

- Radiation or chemotherapy within 4 weeks of enrollment

- Systemic diseases associated with unacceptable anesthesia or operative risk

- Inability to undergo magnetic resonance imaging
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